STA-21 Topical Efficacy on Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT01047943
First received: January 12, 2010
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

The clinical assessment of patients with plaque-type psoriasis is performed by open, intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.


Condition Intervention Phase
Psoriasis
Drug: Topical application of STA-21 ointment for treatment of psoriasis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions

Resource links provided by NLM:


Further study details as provided by Kochi University:

Primary Outcome Measures:
  • Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psoriasis therapy Drug: Topical application of STA-21 ointment for treatment of psoriasis

Detailed Description:

Two discrete psoriatic lesions with a similar size (approximately coin-sized) and clinical severity are selected in each patient. Clinical assessment of psoriatic lesion severity is performed at the baseline and at 1 and 2 (end of treatment) using the scores of erythema, induration, scaling on a scale of 0-4 by two observers. Since STA-21 inhibits Stat3 activation, which is essential for disease activity of psoriasis, topical application of 0.2% STA-21 in Vaseline should improve psoriasis in two weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A history of plaque psoriasis for a minimum of 2 years.
  • In good general health, as evidenced by blood, renal function, and liver function tests conducted before commencing the study.
  • Patients of childbearing age who agreed to continue using birth control for the duration of the study.
  • Men or women between 20 and 80 years old.

Exclusion Criteria:

  • Chronic plaque psoriasis involving >40% of the body surface.
  • Pustular or generalized erythrodermic psoriasis.
  • Use of medications that might affect the psoriasis during the study
  • Systemic therapy for psoriasis within 60 d of baseline.
  • UV therapy within 21 d of baseline.
  • Topical therapy within 14 d of baseline.
  • Positive for HIV, hepatitis B, or hepatitis C.
  • Clinically significant laboratory abnormality in blood, renal function, or liver function.
  • Lactating, pregnant, or planning to become pregnant.
  • Participation in another clinical trial in the last 30 d.
  • Unwillingness to comply with the study protocol.
  • Any other condition that in the opinion of the investigators could compromise the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01047943

Locations
Japan
Department of Dermatology, Kochi Medical School, Kochi University
Nankoku, Japan, 783-8505
Sponsors and Collaborators
Kochi University
Investigators
Principal Investigator: Shigetoshi Sano, M.D., Ph.D. Department of Dermatology, Kochi Medical School, Kochi University
  More Information

No publications provided by Kochi University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Dermatology, Kochi Medical School, Kochi University
ClinicalTrials.gov Identifier: NCT01047943     History of Changes
Other Study ID Numbers: KochiDermaTrial
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014